Top FDA official Peter Marks overruled staff, review team to approve Sarepta gene therapy

Taking stock of the drug industry, from the lab to the medicine chest

June 28, 2024 Check out STAT+

Sponsored By

By Ed Silverman Pharmalot Columnist, Senior Writer

Adobe STAT+ | FDA rejects Rocket Pharmaceuticals' gene therapy for ultra-rare condition, another setback for field The company said that the agency asked it to submit more information to prove it can safely manufacture the product, a treatment for a condition known as LAD-1. By Jason Mast Opinion: To secure the U.S.'s biotech supply chain, pay attention to domestic companies Robust investment in America's domestic supply chain should not overlook new and developing biotech hubs in the Deep South. By Josh Carpenter STAT+ | Don't write off MDMA yet: How the FDA got on board with psychedelics Despite an advisory panel's strong criticisms of MDMA, the FDA's favorable view of psychedelics suggests an approval is quite possible. By Olivia Goldhill

More around STAT

Check out more exclusive coverage with a STAT+ subscription Read premium in-depth biotech, pharma, policy, and life science coverage and analysis with all of our STAT+ articles.

---

Enjoying Pharmalot? Tell us about your experience Continue reading the latest health & science news with the STAT app Download on the App Store or get it on Google Play

STAT, 1 Exchange Place, Boston, MA ©2024, All Rights Reserved. I no longer wish to receive STAT emails

Update Newsletter Preferences     •    Contact Us     •    Advertise with Us     •    View in Browser